Business Model

Sized to fit. Focused on real pediatric medicine.

Our business strategy focuses on reformulating off-patent adult drugs in liquid form to better control dosage in children. Madeira will utilize the 505(b)(2) approval pathway for our drug development programs. The 505(b)(2) process relies in part on the FDA’s findings for a previously approved drug—shortcutting IND approval by years.

Madeira Therapeutics’ executive team and board of advisors are industry experts in drug development, pharmaceuticals and 505(b)(2) applications.

505(b)(2) Pathway